Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-25 @ 4:15 PM
NCT ID:
NCT03213457
Description:
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment.
Arm counts include all randomized participants.
Frequency Threshold:
5
Time Frame:
All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Study:
NCT03213457
Study Brief:
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SCR_Placebo | Screening (SCR) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 0 | 194 | 1 | 194 | View |
| SCR_Elagolix | Screening (SCR) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 0 | 98 | 0 | 98 | View |
| DB_Placebo | Double-blinded (DB) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 8 | 194 | 89 | 194 | View |
| DB_Elagolix | Double-blinded (DB) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 2 | 98 | 74 | 98 | View |
| OL_Placebo_to_ELA_and_E2-NETA | Open-Label (OL) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 7 | 106 | 60 | 106 | View |
| OL_ELA_and_E2-NETA_to_ELA_and_E2-NETA | Open-Label (OL) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 10 | 215 | 125 | 215 | View |
| FU_Placebo_to_ELA_and_E2-NETA | Follow-Up (FU) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 2 | 194 | 2 | 194 | View |
| FU_ELA_and_E2-NETA_to_ELA_and_E2-NETA | Follow-Up (FU) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 1 | 389 | 6 | 389 | View |
| SCR_Elagolix_and_E2-NETA | Screening (SCR) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 1 | 389 | 1 | 389 | View |
| DB_Elagolix_and_E2-NETA | Double-blinded (DB) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 14 | 389 | 236 | 389 | View |
| OL_ELA_to_ELA_and_E2-NETA | Open-Label (OL) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 2 | 59 | 32 | 59 | View |
| FU_ELA_to_ELA_and_E2-NETA | Follow-Up (FU) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. | 0 | None | 0 | 98 | 3 | 98 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| SINUS NODE DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| VESTIBULAR DISORDER | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.1 | View |
| PITUITARY APOPLEXY | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| FOOD POISONING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| INTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| UMBILICAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| BILIARY COLIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| CHOLECYSTITIS CHRONIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| ABSCESS INTESTINAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| COVID-19 PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| ALCOHOL POISONING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| DIABETIC KETOACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| OBESITY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| SPONDYLOLISTHESIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| PITUITARY TUMOUR | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| VESTIBULAR MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| ABORTION SPONTANEOUS | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 26.1 | View |
| CERVICAL INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 26.1 | View |
| ECTOPIC PREGNANCY | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 26.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| PANIC ATTACK | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| SUICIDAL IDEATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| SUICIDE ATTEMPT | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| ENDOMETRIOSIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| HEAVY MENSTRUAL BLEEDING | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| OVARIAN CYST RUPTURED | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| VAGINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| ABORTION INDUCED | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 26.1 | View |
| THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| EAR INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| GASTROENTERITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| VITAMIN D DEFICIENCY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| MOOD SWINGS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| INTERMENSTRUAL BLEEDING | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| NIGHT SWEATS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| HOT FLUSH | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| VULVOVAGINAL MYCOTIC INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| BONE DENSITY DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |